F Zaina1, M Poggio2, F Di Felice2, S Donzelli2, S Negrini3,4. 1. ISICO (Italian Scientific Spine Institute), Milan, Italy. fabio.zaina@isico.it. 2. ISICO (Italian Scientific Spine Institute), Milan, Italy. 3. Department of Biomedical, Surgical and Dental Sciences, University of Milan La Statale, Milan, Italy. 4. IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.
Abstract
PURPOSE: Adult scoliosis is sometimes associated with back pain and severe curves can progress over time. Despite scoliosis has been estimated to affect up to 68% of the population over 60, there is scant literature about conservative treatment for adult scoliosis. Recently, we tested a new brace designed to alleviate pain for adult patients with chronic pain secondary to scoliosis. The study aims to test the efficacy of a prefabricated brace in reducing pain in adult scoliosis patients. METHODS:Twenty adults (age 67.8 ± 10.5, curve 61.9 ± 12.6° Cobb) with chronic low back pain (cLBP) secondary to Idiopathic Scoliosis (IS) were included. Patients were evaluated at baseline immediately before starting with the brace and after 6 months. Outcome measures were GRS, Oswestry Disability Index (ODI), Roland Morris Questionnaire (RM), COMI. The paired t test, ANOVA and Wilcoxon tests were used for statistical analysis RESULTS: At six months, worst pain, leg pain and back pain were significantly improved: from 7.15 to 5.60, from 5.65 to 4.35 and from 6.55 to 5.25 (p < 0.05). Sixty-five percent of patients achieved the minimal clinically important difference of 2 points for worst pain and leg pain, 55% for back pain. RM and COMI improved (p < 0.05), no differences for ODI. CONCLUSION: The prefabricated brace showed a significant improvement at 6 months of worst, leg and back pain in most patients in a group of adult women with IS and cLBP. The quality of life didn't change in a clinically significant way even if the patients reported satisfaction with the treatment. Trial registration number and date of registration: ClinicalTrials.gov Identifier: NCT02643290, December 31, 2015.
RCT Entities:
PURPOSE: Adult scoliosis is sometimes associated with back pain and severe curves can progress over time. Despite scoliosis has been estimated to affect up to 68% of the population over 60, there is scant literature about conservative treatment for adult scoliosis. Recently, we tested a new brace designed to alleviate pain for adult patients with chronic pain secondary to scoliosis. The study aims to test the efficacy of a prefabricated brace in reducing pain in adult scoliosispatients. METHODS: Twenty adults (age 67.8 ± 10.5, curve 61.9 ± 12.6° Cobb) with chronic low back pain (cLBP) secondary to Idiopathic Scoliosis (IS) were included. Patients were evaluated at baseline immediately before starting with the brace and after 6 months. Outcome measures were GRS, Oswestry Disability Index (ODI), Roland Morris Questionnaire (RM), COMI. The paired t test, ANOVA and Wilcoxon tests were used for statistical analysis RESULTS: At six months, worst pain, leg pain and back pain were significantly improved: from 7.15 to 5.60, from 5.65 to 4.35 and from 6.55 to 5.25 (p < 0.05). Sixty-five percent of patients achieved the minimal clinically important difference of 2 points for worst pain and leg pain, 55% for back pain. RM and COMI improved (p < 0.05), no differences for ODI. CONCLUSION: The prefabricated brace showed a significant improvement at 6 months of worst, leg and back pain in most patients in a group of adult women with IS and cLBP. The quality of life didn't change in a clinically significant way even if the patients reported satisfaction with the treatment. Trial registration number and date of registration: ClinicalTrials.gov Identifier: NCT02643290, December 31, 2015.
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